MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS

K993234 · Micromedics, Inc. · ETB · Nov 10, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K993234
• Device Name: MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
• Applicant: Micromedics, Inc.
• Product Code: ETB · Ear, Nose, Throat
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For surgical reconstruction of the sound conduction chain between the stapes and the ear drum, where the stapes is intact and mobile, by replacement of the missing ossicles with a partial implant.

Device Story

S&T Partial Ossicular Replacement Prosthesis; surgical implant used for middle ear reconstruction. Device replaces missing ossicles to restore sound conduction between stapes and ear drum. Used by otolaryngologists in surgical settings. Implant provides structural bridge to facilitate sound transmission; improves patient hearing function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Partial ossicular replacement prosthesis; designed for middle ear implantation. Materials and specific dimensions not detailed in provided text. Non-powered, passive implant.

Indications for Use

Indicated for patients requiring surgical reconstruction of the sound conduction chain between the stapes and the ear drum, specifically where the stapes is intact and mobile, necessitating replacement of missing ossicles with a partial implant.

Regulatory Classification

Identification

A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1999

Mr. Charles Grote Manager of Quality Assurance and Regulatory Affairs Micromedics, Inc. 1285 Corporate Center Drive #150 Eagan, MN 55121

Re: K993234

Device: S&T Partial Ossicular Replacement Prosthesis Dated: September 24, 1999 Received: September 27, 1999 Regulatory Class: II Product Code: 77 ETB

Dear Mr. Grote:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 -- Mr. Charles Grote

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roepl. Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## MICROMEDICS, INC. 510(K) Premarket Notification

510(K) Number: Notknown at this time K993234

Device Name: S&T Partial Ossicular Replacement Prosthesis

## STATEMENT OF INDICATIONS FOR USE

For surgical reconstruction of the sound conduction chain between the stapes and the ear drum, where the stapes is intact and mobile, by replacement of the missing ossicles with a partial implant.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Ophthalmic Devices
510(k) Number K993234

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use